US FDA Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility

FDA has issued a draft guidance to assist blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. This guidance addresses a blood establishment's validation of its Blood Establishment Computer System which incorporates Blood Establishment Computer Software (BECS).

Link to Guidance Document: http://www.fda.gov/cber/gdlns/becsvalid.htm